# FDA 483 - FOUNDATION MEDICINE, INC. - January 28, 2025

Source: https://www.keypedia.com/records/483/foundation-medicine-inc/c1295a87-19ca-4c69-b411-86a70e071a6d

> FDA 483 for FOUNDATION MEDICINE, INC. on January 28, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FOUNDATION MEDICINE, INC.
- Inspection Date: 2025-01-28
- Product Type: device
- Office Name: New England District Office
- Summary: FOUNDATION MEDICINE, INC. in Boston, MA, a manufacturer of cancer biomarker diagnostic tests, was cited for three observations during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, control non-conforming products, and document justifications for not reporting corrections to the FDA. These issues stemmed from a software error in their FoundationOne CDx and Liquid CDx products, which had the potential to result in false negative companion diagnostic tests.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/foundation-medicine-inc/76ba405e-202e-425f-962e-ba5144daf0bd

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144